Adjuvant Chemotherapy in High-Grade Uterine Leiomyosarcoma

Key Points

The trial was stopped due to accrual futility.

The available data suggest no benefit of adjuvant chemotherapy.

As reported in the Journal of Clinical Oncology by Hensley et al, a phase III NRG Oncology/Gynecologic Oncology Group study assessing adjuvant chemotherapy vs observation in disease-free patients with uterus-confined high-grade leiomyosarcoma was stopped due to accrual futility; available data suggested no benefit of adjuvant chemotherapy.

Study Details

The trial had a targeted accrual of 216 patients. With international collaboration, only 38 patients were enrolled, with the study being closed by the National Cancer Institute due to accrual futility. All patients had to have a complete hysterectomy with or without bilateral salpingo-oophorectomy within 12 weeks of study enrollment and no evidence of persistent or metastatic disease on postresection imaging. Of the 38 patients, 17 were randomized to receive adjuvant chemotherapy with 4 cycles of gemcitabine plus docetaxel followed by 4 cycles of doxorubicin, and 18 were randomized to observation.

The primary endpoint was overall survival. Patients were followed for evidence of recurrence.

Treatment Outcomes

Overall, six deaths occurred—five in the chemotherapy and one in the observation group—all due to disease. The restricted mean overall survival duration was estimated at 34.3 months in the chemotherapy group and 46.4 months in the observation group. Recurrence was observed in 8 patients in each group; the restricted mean recurrence-free survival duration was estimated at 18.1 months vs 14.6 months. A stated by the investigators, “Neither survival outcome comparison was considered statistically robust, due to the small sample size.”

Grade 3 or 4 adverse events occurred in 47% of the chemotherapy group vs 1 patient in the observation group.

The investigators concluded, “Despite international collaboration to test the role of adjuvant chemotherapy in uterine-confined leiomyosarcoma, this study was closed for accrual futility. Although the sample size precludes robust statistical comparison, observed [overall survival] and recurrence-free survival data do not show superior outcomes with adjuvant chemotherapy.”

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